Mealtime Interactions and Risk of Toddler Obesity

February 2, 2021 updated by: Temple University

Mealtime Interactions and Risk of Obesity in Toddlers

The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934 will be invited to participate in this observational study.

Description

Inclusion Criteria:

  • Mother participated in clinical trial #NCT01545934
  • Child 18-36 months old

Exclusion Criteria:

  • Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Behavioral: Lifestyle Intervention
The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
No Intervention: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responsive feeding
Time Frame: 18- and 24-months
The Responsiveness to Child Feeding Cues Scale will be used to code maternal responsive feeding. Primary outcomes are: a) maternal responsiveness to toddler fullness cues.
18- and 24-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Weight Status
Time Frame: birth, 6-, 12-, 18-, 24- and 36-months
zBMI will be computed at each time point
birth, 6-, 12-, 18-, 24- and 36-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Miriam Hospital
California Polytechnic State University-San Luis Obispo

Investigators

  • Principal Investigator: Rena Wing, PhD, The Miriam Hospital
  • Principal Investigator: Suzanne Phelan, PhD, California Polytechnic State University-San Luis Obispo
  • Principal Investigator: Chantelle Hart, PhD, Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23356
  • R01DK108661 (U.S. NIH Grant/Contract)
  • R56DK108661 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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